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Adverse Event Report

CIBA VISION CORP. CIBA VISION MEMORYLENS INTRAOCULAR LENS   back to search results
Model Number U940A
Event Date 01/14/2002
Event Type  Injury  
Event Description

An audix report was received on 06/2002 regarding a memorylens which had been implanted in 2000 in a patient's left eye, which lens had opacified. The lens was explanted in 2002 and replaced. The patient had a pre-existing medical history of diabetes. The lens was replaced without complication, and the patient's visual acuity at last follow-up in 2002 was 20/20 os.

 
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Brand NameCIBA VISION MEMORYLENS
Type of DeviceINTRAOCULAR LENS
Baseline Brand NameCIBA VISION MEMORYLENS
Baseline Generic NameINTRAOCULAR LENS
Baseline Catalogue NumberU940A
Baseline Model NumberU940A
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CIBA VISION CORP.
el jibaro industrial park
lot #2, po 1358
cidra PR 00739
Manufacturer (Section D)
CIBA VISION CORP.
el jibaro industrial park
lot #2, po 1358
cidra PR 00739
Manufacturer Contact
sandra wilkerson
11460 johns creek parkway
duluth , GA 30097
(678) 415 -3121
Device Event Key393060
MDR Report Key404069
Event Key381877
Report Number2648694-2002-00061
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/12/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/11/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date07/21/2000
Device MODEL NumberU940A
Device Catalogue NumberU940A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/12/2002
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/1999
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/11/2002 Patient Sequence Number: 1
#TreatmentTreatment Date
1,NONE REPORTED.,

Database last updated on December 31, 2008

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